Adapt Pharma® Presents Human Factors Study Data on Usability of NARCAN® (naloxone HCl) Nasal Spray at the 41st Association for Medical Education & Research in Substance Abuse Annual National Conference
Source:

PRNewswire

November 3, 2017

DUBLIN, Nov. 3, 2017 /PRNewswire/ — Adapt Pharma, Inc. (www.adaptpharma.com) presented findings from two human factors studies conducted, as a part of its Food and Drug Administration (FDA) product approval, to evaluate the usability of NARCAN® Nasal Spray by adolescents and individuals including those with low literacy. The poster titled, Usability of Naloxone Nasal Spray By Age and Literacy Level: A Pooled Analysis of Human Factors Studies, was presented at the 41st Association for Medical Education and Research in Substance Abuse (AMERSA) Annual National Conference in Washington, D.C. on Thursday, November 2, 2017.

 

“The study suggested that a bystander population can administer NARCAN® Nasal Spray with no previous experience or training,” said lead author Melissa Beck, B.A., Concentrics Research. “This ready-to-use nasal spray is designed for effective delivery of this potentially life-saving medication to those experiencing an opioid-related overdose while waiting for emergency medical care to arrive.”

 

The data demonstrated that, without instruction or training, a diverse cross section of the population (adults and adolescents, normal and low literate) can complete the critical steps necessary to properly deploy NARCAN® Nasal Spray in simulated emergency situations. The data also demonstrated that the understanding of key concepts in the patient information section of the package insert was high among study participants regardless of age or literacy level. Results suggested that NARCAN® Nasal Spray can be administered by a bystander population with no training or advanced review of product instructions.

 

*It is important to note that while this study was conducted to evaluate the product’s usability, Adapt Pharma® always recommends that individuals review and have a complete understanding of the Patient Information and Instructions for Use for NARCAN® Nasal Spray.

 

NARCAN® Nasal Spray 4mg is the first and only FDA-approved, needle-free formulation of naloxone for the emergency treatment of a known or suspected opioid overdose. It does not require assembly or any specialized medical training and is also the highest concentrated dose of intranasal naloxone currently available. NARCAN® Nasal Spray is not a substitute for emergency medical care, and additional doses of NARCAN® Nasal Spray may be required until emergency medical assistance arrives. Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance. Please see Indications and Important Safety Information below.

 

Indications

 

NARCAN® (naloxone hydrochloride) Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN® Nasal Spray is not a substitute for emergency medical care.

 

Important Safety Information

 

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.

 

Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

 

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

 

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

 

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes. Monitor for the development of opioid withdrawal.

 

Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.

 

Adverse Reactions: The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.

 

To report SUSPECTED ADVERSE REACTIONS, contact ADAPT Pharma, Inc. at 1-844-4NARCAN (1-844-462-7226) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Please see full Prescribing Information at: https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf.

 

For additional information on NARCAN® Nasal Spray, please visit www.NARCAN.com.

 

ABOUT ADAPT PHARMA®

Adapt Pharma® is a privately-held pharmaceutical company committed to positively impacting the lives of patients. Adapt Pharma’s strategy is to identify, evaluate, selectively acquire and enhance the value of late stage development, and FDA approved, pharmaceutical products. Adapt Pharma’s company headquarters is in Dublin, Ireland and its U.S. headquarters is in Radnor, Pennsylvania. For more information, please visit www.adaptpharma.com.

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